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USA authorizes use of remdesivir against coronavirus 0:44
(CNN) - The federal government will begin sending "tens of thousands" of remdesivir treatments earlier this week and will decide where the drug goes, according to Daniel O'Day, president and CEO of Gilead Sciences, the drug's maker. in research.
In the first results of a trial sponsored by the National Institutes of Health, remdesivir was found to shorten the duration of illness in patients with severe covid-19, but had no statistically significant effect on whether the patients died.
"We intend to bring [remdesivir] to patients early this next week, starting to work with the government, which will determine which cities are most vulnerable and where are the patients who need this medication," O'Day said in " CBS 'Face the Nation ”this weekend.
LOOK: The ABC of possible treatments against coronavirus: remdesivir, hydroxychloroquine, famotidine and others
CNN has contacted the US Department of Health and Human Services. USA For feedback on how medications will be distributed.
The government will begin to send 'tens of thousands of treatments'
Earlier this week, the US Food and Drug Administration. USA He authorized remdesivir for emergency use in patients with severe covid-19, and Gilead previously announced that he would donate his existing supply of the drug.
"What we will do is provide that donation to the US government. Based on things like ICU beds, they will determine where the epidemic is advancing in the United States. They will start sending tens of thousands of treatments early this week and we will adjust as the epidemic changes and evolves in different parts, in different cities here in the United States, "O'Day said Sunday.
His comments echo the FDA's emergency use authorization for the drug, which says: "The distribution of the authorized remdesivir will be controlled by the United States Government for use consistent with the terms and conditions."
USA authorizes use of remdesivir against coronavirus 0:44Gilead has donated 1.5 million vials of the drug, O'Day said, which is equivalent to 100,000 to 200,000 treatments, depending on how long patients take it.
"This donation will be available to patients here in the United States and around the world as other regulatory decisions are made for those countries," he said.
When asked if the Trump administration has discussed using the Defense Production Law to order prioritization of the US market. USA On foreign markets, O'Day said: "I think we are aligned with the US government. USA to serve patients here in the United States and to make sure, as a global company based here in the US, that we can serve other countries around the world as well. ”
Margaret Brennan of CBS then asked for confirmation: “So they haven't talked to you about ordering the US market be prioritized. USA, or take them for supply, for example. Can you still export it? ”
LOOK: What you should know about the medication remdesivir that could be used to treat coronavirus
"That's correct," said O'Day. “We have been exporting thousands of treatments for clinical trials and for compassionate use. And our collaboration with the government has been such that we have been very transparent with them here in the United States, and we have a good relationship in the future assignment. ”
The company expects to produce one million treatments by the end of the year.
When asked to clarify whether all 1.5 million vials would be donated to the US government. As suggested by O'Day, Gilead spokeswoman Sonia Choi said, "We intend to allocate our available supply based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment."
She said the company "is working with regulatory authorities around the world and bioethicists to help inform our global allocation approach."
In a press release this Friday, Gilead said his goal is to produce at least 500,000 treatments by October and more than a million by December.
The FDA-authorized drug is infused intravenously and its use is limited to hospitalized patients with severe illness. But O'Day said Gilead is also looking at other formulations of remdesivir, including an inhaled version that could be administered outside of the hospital.
